BIOTRONIK Lumax 540 VR-T, Lumax 540 HF-T, Lumax 540 VR-T DX, Lumax 540 DR-T Technical Manual
Lumax 540
ICD Family
Skupina výrobků ICD
ICD-familie
ICD Familie
Familia DAI
Rytmihäiriötahdistimien tuoteperhe
Famille DAI
ICD-család
Famiglia di ICD
ICD-familien
Rodzina kardiowerterów-debrylatorów
Família CDI
ICD-serien
ICD-ailesi
ICD 系列
Technical Manual
Technická příručka
Brugermanual
Gebrauchsanweisung
Manual técnico
Käyttöohje
Manuel technique
Használati útmutató
Manuale tecnico di istruzioni
Manual
Instrukcja obsługi
Manual técnico
Bruksanvisning
Teknik Manuel
技术手册
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System Description
Intended Medical Use
Lumax is the name of a family of implantable cardioverter-defibrillators (ICDs).
Primary objective of the therapy is to prevent sudden cardiac death. The aim is to automatically detect and terminate cardiac arrest caused by ventricular tachyarrhythmia.
All major therapeutical approaches from the field of cardiology and electrophysiology
are contained within the Lumax family.
Furthermore, the device is capable of treating bradycardia arrhythmias and congestive
heart failure with multisite ventricular pacing – known as cardiac resynchronization
therapy.
The integrated Home Monitoring component can provide information about occurring
rythm disturbances and delivered therapies close to real time as well as by IEGM
Online HD®. Furthermore, statistical data about the patient's condition as well as information about the integrity status of the device itself are sent.
The implantation of an ICD is a symptomatic therapy with the following objectives:
•
Termination of spontaneous ventricular fibrillation (VF) through shock delivery
•
Termination of spontaneous ventricular tachycardia (VT) through antitachycardia
pacing (ATP); in case of ineffective ATP or hemodynamically not tolerated VT, with
shock delivery
•
Cardiac resynchronization through multisite ventricular pacing (triple-chamber
device)
•
Compensation of bradycardia through ventricular (single-chamber device) or
AV sequential pacing (dual- and triple-chamber device)
Required expertise
In addition to having basic medical knowledge, the user must be thoroughly familiar
with the operation of a device system. Only qualified medical specialists having the special knowledge required for the proper use of devices are permitted to use them. If
users do not possess this knowledge, they must be trained accordingly.
ICD System
Lumax
The Lumax ICD system consists of the following:
•
Single-, dual- or triple-chamber device with connections for bipolar sensing and
pacing as well as connections for shock delivery
•
ICD leads:
—
One bipolar ICD lead with one or two shock coils for the ventricle (single-chamber device)
—
One bipolar lead for the atrium and one bipolar ICD lead for the ventricle
respectively with one or two shock coils (dual-chamber or triple-chamber
device)
—
One uni- or bipolar CS lead (coronary sinus lead for the triple-chamber device)
•
Programmer with current device program
Device
The device's housing is made of biocompatible titanium, welded from outside and thus
hermetically sealed. It serves as a potential antipole during shock delivery. The ellipsoid shape facilitates implantation in the pectoral muscle area.
The labeling provides information about the device type and the arrangement of the
connections.
Lumax family
The following types with Home Monitoring are available (some device types are not
available in all countries):
NBD and NBG codes
VVE is the NBD code for the antitachycardia mode of the single-chamber, dual-chamber and triple-chamber devices:
Note:
A tripolar or quadrupolar RV lead has bipolar electrodes as well as 1 or 2 shock
coils.
Device High energy type: max. 40 J
Single-chamber Lumax 540 VR-T
Lumax 540 VR-T DX
Dual-chamber Lumax 540 DR-T
Triple-chamber Lumax 540 HF-T
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3
DDDR is the NBG code for the antibradycardia mode of the dual-chamber and triplechamber devices:
VVIR is the NBG code for the antibradycardia modes of the single-chamber devices:
ICD leads
The leads are sheathed with biocompatible silicone. They can be flexibly maneuvered,
are long-term stable, and are equipped for active or passive fixation. They are
implanted using a lead delivery set. Some leads are coated with polyurethane which
is known to increase the sliding properties for the lead.
Leads with steroids reduce inflammatory processes. The fractal design of the electrodes provides for low pacing thresholds.
Device/ICD lead connection scheme
BIOTRONIK ICDs are designed for connection to ICD leads with a bipolar IS-1 connection (pacing/sensing) and DF-1 connection for shock coils.
Connection schemes of the device types:
Device and lead connections:
Possible technical failures
In principle, technical failures in the device due to component failures cannot be ruled
out; they occur, however, very rarely. Possible causes of such malfunctions include the
following:
•
Battery depletion
•
Lead dislodgment
•
Lead fracture
•
Insulation defects
Programmer
The portable programmer is used to transfer the current device program to the device.
In addition to this, the programmer is used for interrogation and storage of data from
the device. The programmer acts as an ECG and IEGM monitor with Miniclinic.
The programmer communicates with the device via the programming head. It has a TFT
touch screen with a color display, on which the ECG, IEGM, marker and functions are
shown simultaneously.
The programmer has, among others, the following functions:
•
Perform all tests during in-office follow-up
•
Display and print real-time and saved IEGMs with annotated markers
•
Determine the pacing threshold
V Shock in the ventricle
V Antitachycardia pacing (ATP) in the ventricle
E Detection via IEGM analysis
D Pacing in both chambers
D Sensing in both chambers
D Pulse inhibition and pulse triggering
R Rate adaptation
VVentricular pacing
V Sensing in the ventricle
I Pulse inhibition in the ventricle
R Rate adaptation
Note:
Device and lead have to match; Kentrox A+ Steroid and Linox Smart DX leads
match the Lumax 540 VR-T DX.
Note:
A bipolar as well as a unipolar coronary sinus lead can be connected to the left
ventricular CS connection of the Lumax HF variant. Several pacing polarities can be
set with a bipolar CS lead.
VR-T VR-T DX DR-T HF-T
VR-T VR-T DX DR-T HF-T
Atrium — IS-1 bipolar
Right ventricle IS-1 bipolar
2 x DF-1 unipolar
Left ventricle — IS-1 unipolar or bipolar
RV
SVC
SVC
RV
SVC
RV
RV
SVC
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4
BIOTRONIK Home Monitoring
®
In addition to effective pacing therapy, BIOTRONIK provides a complete therapy
management system:
•
With Home Monitoring, diagnostic and therapeutic information and technical data
are automatically sent to a stationary or mobile transmitter via an antenna in the
device header. The data are encrypted and sent from the transmitter to the
BIOTRONIK Service Center via the cellular phone network.
•
The received data are deciphered and evaluated. Each physician can set the criteria
for evaluation to be used for each patient and can configure the time of notification
via E-mail, SMS or fax.
•
A clear overview of the analysis results is displayed for the attending physicians on
the protected Internet platform HMSC (Home Monitoring Service Center).
•
Data transmission from the device is performed with a daily device message.
•
Device messages, which indicate special events in the patient's heart or in the
device, are forwarded immediately.
Technical manuals
The following technical manuals provide information about usage of the device system:
•
Technical manual for the device
•
Technical manual for the HMSC
•
Technical manual for the programmer
•
User manual for the device program:
—
As a help function in the user interface
—
As a file on CD
•
Technical manual for the leads
•
Technical manual for cables, adapters and accessories
Therapeutic and Diagnostic Functions
Overview
Depending on the type, the device program contains not only the ICD functions but also
all PM functions for 1, 2, or 3 chambers. The patient's heart rhythm is continuously
monitored; each arrhythmia is classified according to the heart rate and the adjustable
detection criteria. Depending on the preset values, antibradycardia as well as antitachycardia therapy is inhibited or delivered.
Antitachycardia pacing
The ICD can treat ventricular tachycardia with antitachycardia pacing (ATP); ATP can
also be delivered in the VF zone (ATP One Shot) when the rate stability indicates that
this will be effective before shock delivery (monomorphic rapid VTs).
Cardioversion, defibrillation
The ICD can treat ventricular tachyarrhythmia with cardioversion and/or defibrillation.
Shock polarity and energy can be programmed for individual therapies. Shock energies
between 1.0 and 40 J are possible. Before delivery of the first shock, the ICD can verify
that the tachyarrhythmia is still ongoing; in this verification mode the device can identify spontaneous conversion of the tachyarrhythmia and cancel shock delivery.
•
The shock paths can be set between the different shock coils (SVC/RV) and/or the
housing.
Home Monitoring: Message retrieval
The device sends information to the service center in two ways; automatically once a
day, and when triggered by certain events. All data can be viewed on the Internet subsequently.
•
IEGM-Online HD® with 3 channels in high resolution (High Density) with annotated
markers
•
Direct information on sustained atrial arrhythmia including IEGM Online HD
•
Regular IEGM recordings of the intrinsic rhythm for remote diagnosis
•
Daily transmission of atrial heart rate variability (SDANN)
Transmission of the following data:
•
Device settings
•
Impedance measurement values
•
Sensing measurement values
•
30-second IEGM recording
•
Statistics
Transmission is carried out on a weekly or monthly basis.
Antibradycardia pacing
Innovative rate hystereses, automatic sensor functions, and a night program promote
the patient's intrinsic rhythm, avoid overdrive pacing, and facilitate adaptation of the
device to the individual needs of the patient.
Positive AV hysteresis functions support the intrinsic conduction and thus the natural
contraction sequence. Negative AV hysteresis functions support the cardiac resynchronization therapy by maintaining pacing in stress situations.
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5
•
For resynchronization of the ventricles, 3-chamber devices have functions for
multisite ventricular pacing with possible VV delays in either direction.
•
To ensure that no additional surgery is necessary in case of a left-sided increase of
pacing threshold or undesired phrenic nerve stimulation by the CS lead, different
pacing polarites can be set for the CS lead with a triple-chamber device.
•
Setting an upper pacing rate for the atrium prevents unspecific atrial pacing, thus
improving the termination of pacemaker-mediated tachycardia.
•
Automatic threshold monitoring (ATM) for the left and right ventricle
Diagnostic functions
The device can record several types of arrhythmia episodes and store them in the
Holter memory:
•
VT/VF therapy episodes
•
SVT episodes (requirement SMART)
•
VT monitoring zones
•
AT/AF monitoring zones
The device stores diagnostic data about arrhythmia episodes:
•
Detection counter and therapy counter
•
Temporal characteristics of the episode
•
Details on the last ATP and shock deliveries
•
Shock data
•
Therapy history
•
Triple-channel IEGMs including marker channels, up to 30 min
Comprehensive memory functions such as histograms, Holter, mode switching longand short-term trends and the activity reports facilitate the evaluation of both patient
and device status.
The follow-up assistant functions have been largely automated.
The shock impedance is measured in an automatic procedure involving below-threshold electrical pulses. This process is painless for the patient. The impedance values are
automatically measured 4 times a day. They are averaged and provided in a trend in the
device and via Home Monitoring.
Painless measurement of shock impedance can also be carried out manually with the
programmer.
•
Lumax 540 VR-T DX is new (DX stands for diagnostics): Only one lead is required for
improved detection of AT and AF even with a single-chamber device. This enables
sensing in the atrium and ventricle as well as AV-sequential pacing. The SMART
algorithm helps distinguish more clearly between SVT and VT. The IEGM is
recorded in both chambers.
Prior to Implantation
Indications
Lumax ICDs can treat life-threatening ventricular arrythmias with antitachycardia
stimulation and defibrillation.
Single- and dual-chamber ICD
Lumax single and dual chamber ICDs are indicated for patients with the following risk:
•
Sudden cardiac death caused by ventricular arrhythmias
Triple-chamber ICD
Lumax triple-chamber ICDs are indicated for patients with the following threats:
•
Sudden cardiac death caused by ventricular arrhythmias
•
Congestive heart failure with ventricular asynchrony
Lumax ICDs are also indicated for primary prophylaxis in congestive heart failure
patients.
Contraindications
Known contraindications:
•
Tachyarrhythmia caused by temporary or reversible irritation e.g. poisoning,
electrolyte imbalance, hypoxia, sepsis or acute myocardial infarction
•
Such frequent VT or VF that the therapies would cause an unacceptably rapid
depletion of the device batteries
•
VT with few or without clinically relevant symptoms
•
VT or VF treatable by surgery
•
Concomitant diseases that would substantially limit a positive prognosis
•
Accelerated idioventricular rhythm
Shipping and Storage
Information on the package
The storage package for the device comprises a folded cardboard box with a quality
control seal and a label.
•
Device name with serial number and PID number
•
Technical details
•
Details on sterility and use by date
•
Ambient conditions during shipping and storage
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6
Ambient conditions
5°C to 45°C
Storage location
•
Devices are not to be stored close to magnets or sources of electromagnetic interference.
Implantation
Sterility
Delivery
The device and the accessories have been gas sterilized. Sterility is guaranteed only if
the plastic container and quality control seal have not been damaged.
Sterile container
The device and accessories are packaged respectively in two separately sealed plastic
containers. The inner plastic container is also sterile on the outside so that it can be
transferred in a sterile state during implantation.
Preparing the Implantation
Having the required parts ready
•
Device with blind plug DF-1 and IS-1
•
BIOTRONIK ICD leads complying with the requirements of EC Directive 90/385/EEC,
and lead delivery set
•
BIOTRONIK programmer complying with the requirements of EC Directive 90/385/
EEC
—
ECG cable PK-222
—
2 PK-141 patient cables or 2 PK-67 patient cables, either with patient adapters
PA-2 or PA-4 for connection of the pacing and sensing leads (IS-1) to ICS (dual and triple-chamber devices)
—
1 PK-144 patient cable with patient adapter PA-3 for connection of shock coils
(DF-1) to the programmer
•
External multi-channel ECG recorder/monitor
•
External defibrillator and paddles or adhesive electrodes.
Unpacking the device
Proceed as follows:
Connecting ICD Leads
Precautionary measures
Note:
Ensure that sterile spare parts are available for all parts that are to be
implanted.
W
WARNING
Non-terminated ventricular arrhythmia
If the ICD does not deliver an adequate therapy, ventricular arrhythmia is not terminated.
•
Keep an external defibrillator ready.
W
WARNING
Inadequate therapy due to previously damaged device
If the unpacked device is dropped on a hard surface during handling, discontinue use
and return it to BIOTRONIK. Use a replacement device.
1 Peel off the sealing paper of the non-sterile outer plastic container at the
marked position in the direction indicated by the arrow.
The inner plastic container may not come into contact with persons who have not
sterilized their hands or gloves, nor with non-sterile instruments.
2 Take hold of the inner plastic container by the gripping tab and take it out the
outer plastic container.
3 Peel off the sealing paper of the sterile inner plastic container at the marked
position in the direction indicated by the arrow.
Note:
Use only adapters approved by BIOTRONIK for ICD leads with different connections. Should you have questions about the compatibility of other manufacturers' ICD
leads, please contact BIOTRONIK.
W
WARNING
Short circuit due to open lead connections
Open – and thus not electrolyte-proof – IS-1 or DF-1 connections may cause undesired current flows to the body and penetration of body fluid into the device.
•
Close unused DF-1 connections with the blind plug DF-1, unused IS-1 connections with the blind plug IS-1.
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7
Connecting the ICD lead connector to the device
Leads are connected to the device according to the diagram on the header. Proceed as
follows:
Setting the lead polarity manually
Due to the risk of an entrance/exit block, bipolar lead polarity (sensing/pacing) should
only be set if bipolar leads are implanted.
Implanting the ICD
Implantation site
In general the ICD is implanted subpectorally on the left depending on the lead
configuration as well as the anatomy of the patient.
ICD status prior to implantation
The ICD is shipped in a deactivated mode and can be connected and implanted in this
state.
W
WARNING
Far-field sensing or insufficient defibrillation
When shock coils and pace/sense electrodes are not spaced sufficiently apart or
positioned inappropriately, this can lead to far-field sensing or insufficient defibrillation:
•
The distance between two shock coils must be greater than 6 cm.
•
Pace and sense electrodes must not contact each other.
W
CAUTION
Damage to the header while handling the blind plug
For every connection there is a blind plug in the header; the provided set screws must
be carefully loosened or tightened.
•
Loosen set screws with the supplied screwdriver. Use BIOTRONIK screwdrivers
with torque control only!
•
Do not forcibly pull out the blind plug!
•
If lead repositioning is necessary, re-order sterile screwdrivers from BIOTRONIK.
W
WARNING
Malfunctioning of the therapy functions or triggering of tachycardia by older,
unused leads
If, upon replacing the device, predecessor leads are no longer used but left where
they are, then their connections have to be insulated so that there is no additional
uncontrolled current path to the heart.
1 Disconnect stylets and insertion aids from the lead connector.
2
•
Connect ventricle shock coil to RV.
•
Connect vena-cava shock coil or subcutaneous shock coil to SVC.
3
•
Connect the bipolar IS-1-lead connector atrium to A S or P/S A.
•
Connect the bipolar IS-1 lead connector ventricle to P/S V.
•
Connect the unipolar or the bipolar IS-1 lead connector of the CS lead
to P/S CS.
4 Push the lead connector into the header without bending the conductor until the
connector tip becomes visible behind the set screw block.
5 If the lead connector cannot be inserted completely, the set screw may be
protruding into the cavity of the set screw block.
Carefully loosen the set screw without completely unscrewing it, so that it does
not become tilted upon retightening.
6 Use the screwdriver to perpendicularly pierce through the slitting in the center
of the silicone plug until it reaches the set screw.
7 Turn the set screw clockwise until the torque control starts (you will hear a
clicking sound).
8 Carefully withdraw the screwdriver without retracting the set screw.
•
Bipolar IS-1 connectors: tighten both set screws!
•
When you withdraw the screwdriver, the silicone plug automatically seals
the lead connection safely.
W
CAUTION
Shipment mode active!
During shipment, the device has been set to shipment mode.
The shipment mode reduces the battery's energy consumption, which may increase
longevity. The shipment mode controls the charge time of automatic capacitor reformations.
The shipment mode must be deactivated before the conclusion of the implantation
procedure.
The shipment mode will be automatically deactivated
as soon as electrophysiolo-
gical tests (e.g. impedance measurement) have been performed.
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8
Notes on applying a programming head (PGH)
The programming head (PGH) features a diagram of the device to assist in positioning
the head.
•
Make sure the PGH is positioned correctly to ensure proper telemetry.
Notes on applying a permanent magnet
Applying a permanent magnet interrupts sensing and therapy of tachycardia events.
After 8 hours of this type of deactivation, the device automatically activates the therapy
functions again to prevent unintentional permanent deactivation.
•
If detection interruptions of longer than 8 hours are required, the magnet has to be
briefly removed from the device. The 8 hour countdown restarts when the magnet
is applied again.
•
Use BIOTRONIK accessories, permanent magnets of type M-50 or programming
head PGH with magnet.
Sequence
Proceed as follows:
Activating the ICD
Proceed as follows:
After Implantation
Follow-up
Follow-up intervals
Follow-ups must be performed at regular, agreed intervals.
•
The first follow-up should be carried out by the physician using the programmer
(in-office follow-up) approximately 3 months after implantation following the lead
ingrowth phase.
•
The next in-office follow-up should be carried out once a year and no later than
12 months after the last in-office follow-up.
W
WARNING
Unintentional shock delivery
A shock could be delivered when handling an activated ICD.
•
If an already activated ICD is to be implanted: turn off ICD therapy.
W
WARNING
Interference of heart rate monitoring
Radio frequency as during electrocautery can interfere with electromyografic monitoring, e.g. be interpreted as arrhythmia and trigger a shock.
•
Turn off the detection function of the ICD during cauterization; the pacemaker
function can remain active.
•
Additionally check the peripheral pulse of the patient.
1 Shape the device pocket and prepare the vein.
2 Implant the ICD leads and perform measurements.
3 Connect the device and ICD leads.
4 Insert the device.
5 Check the device with standard tests.
6 Close the device pocket.
W
WARNING
Telemetry interference with inadequate pulse amplitude
If the pulse amplitude of the temporary program is not effective, the patient may get
into a hemodynamically critical condition. Telemetry interference can prevent correction of the critical amplitude.
•
Lift the programming head 30 cm; the device switches automatically to the
permanent program.
W
WARNING
Loss of pacing during exclusively left ventricular pacing
When only LV pacing is set and lead displacement occurs, the following dangers exist:
loss of ventricular pacing and the ATP therapy as well as induction of atrial arrhythmia.
•
Carefully check the pacing parameters.
1 Select the device program for Lumax on the programmer.
W
WARNING
No ICD therapy as delivered
At the time of delivery, the device is programmed with the factory settings.
2 Activate ICD therapy.
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9
Follow-up with BIOTRONIK Home Monitoring®
Monitoring using the Home Monitoring function does not serve to replace regular
in-office appointments with the physician required for other medical reasons.
Follow-up supported by Home Monitoring can be used to functionally replace in-office
follow-up under the following conditions:
•
The patient was informed that the physician must be contacted if symptoms worsen
or if new symptoms arise despite use of the Home Monitoring function.
•
Device messages are transmitted regularly.
•
The physician decides whether the data transmitted via Home Monitoring with
regard to the patient's clinical condition as well as the technical state of the device
system are sufficient. If not, an in-office follow-up has to be carried out.
Possible early detection due to information gained via Home Monitoring may necessitate an additional in-office follow-up. For example, the data may indicate at an early
stage lead problems or a foreseeable end of service time (ERI). Furthermore the data
could provide indications of previously unrecognized arrhythmias or modification of the
therapy by reprogramming the device.
Follow-up with the programmer
Use the following procedure for in-office follow-up:
Note for physicians
Use the patient ID card to obtain information on magnet behavior and tachyarrhythmia
detection.
Notes for patients
A patient brochure and a patient ID card are supplied with the device.
•
Provide the patient with the patient brochure and patient ID card.
•
Draw the patient's attention to prohibitory signs:
places with prohibitory signs must be avoided.
Replacement Indication
Foreword
The battery level can be continuously monitored with Home Monitoring and checked
during follow-ups.
Possible battery levels
•
BOL: Beginning of Life (i.e. BOS: Beginning of Service): 70% charge
•
MOL 1: Middle of Life : 70% to 40% residual charge
•
MOL 2: Middle of Life : 40% residual charge
•
ERI: Elective Replacement Indication, (i.e. RRT: Recommended Replacement Time)
•
EOS: End of Service
ERI
The device can monitor the cardiac rhythm for at least 3 months and deliver at least six
maximum energy shocks until EOS.
The selected parameters in the device program do not change.
1 Record and evaluate the external ECG.
2 Check the sensing and pacing functions.
3 Interrogate the device.
4 Evaluate the status and automatically measured follow-up data.
5 Possibly evaluate statistics and Holter/IEGM recording.
6 Manually perform standard tests if necessary.
7 Possibly customize program functions and parameters.
8 Transmit the program permanently to the device.
9 Print and document follow-up data (print report).
10 Finish the follow-up for this patient.
W
WARNING
Possible loss of left ventricular pacing if the pacing threshold has been determined
exclusively by ATM
The pacing threshold determined by ATM should not be used directly to determine the
left ventricular pacing amplitude (LV). The effectiveness of the LV pacing amplitude
has to be confirmed.
W
CAUTION
Temporally limited therapy
When the ERI display is noticed for the first time during a follow-up, the remaining
service time can be much less than 3 months even if follow-ups have been performed
at three month intervals.
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10
Action on ERI
Proceed as follows:
EOS
•
End of Service can be detected by Home Monitoring.
•
VT and VF detection and all therapies are deactivated.
•
The antibradycardia function remains active in the VVI mode:
—
Basic rate 50 ppm
—
Without special pacemaker functions, such as hysteresis, etc.
—
Amplitude of 6 V
—
Pulse width of 1.5 ms
Action on EOS
Proceed as follows:
Explantation and Disposal
Explanting the ICD
Proceed as follows:
Disposing of the ICD
Proceed as follows:
Cautionary Notes
Medical Complications
General information on possible complications
It is impossible to guarantee the efficacy of antitachycardia or fibrillation therapy, even
if these therapies have proved successful during intraoperative tests or subsequent
electrophysiological tests. In rare circumstances, the set therapies may prove ineffective or, in unfavorable conditions, even life-threatening. It is possible for therapies to
induce or accelerate tachycardia and cause sustained ventricular flutter or fibrillation.
Known possible complications:
The following are some of the known medical complications related to pacemaker
therapy and ICD therapy:
•
Formation of necrotic tissue
•
Vascular damage
•
Thrombosis
1 Replace device soon.
W
WARNING
EOS before explantation
If EOS occurs before replacement of the device, the patient is without antiarrhythmic
therapy and thus at risk of a life threatening condition!
1 Replace device immediately.
2 Monitor patient constantly until immediate replacement of the device!
Note:
Before the cremation of a deceased patient, the device must be explanted.
W
WARNING
Unintentional shock delivery
A shock could be delivered when handling an activated ICD. Devices may not be
explanted when detection is activated.
•
Turn off the detection function before explantation.
•
Do not simply cut the ICD leads.
1 Interrogate the device status.
2 Deactivate VT and VF therapies.
3 Disconnect the leads from the header.
4 Remove the device and leads using state-of-the-art technology.
5 Dispose of the device in an environmentally safe manner.
6 Fill out explantation form and send to BIOTRONIK.
Note:
Normal oxidation processes may cause ICD housing discolorations. This is
neither a device defect nor does it influence device functionality.
1 Clean the explant with an at least 1% sodium-hyperchlorine solution.
2 Rinse off with water.
3 Send to BIOTRONIK for disposal in an environmentally safe manner.
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11
•
Embolism
•
Increase in pacing threshold
•
Detection failures
•
Foreign body rejection
•
Cardiac tamponade
•
Muscle or nerve stimulation
•
Device-induced arrhythmias
•
Perforation of device pockets
•
Infections
•
Psychological intolerance or psychological dependency
Actions to prevent device-induced complications
Skeletal myopotentials
Bipolar sensing and control of sensitivity are adapted by the device to the rate spectrum
of intrinsic events so that skeletal myopotenials are usually not detected. Skeletal myopotentials can very rarely be sensed as intrinsic events and, depending on the interference pattern, may provoke inhibition or antiarrhythmia therapy.
Risky Therapeutic and Diagnostic Procedures
External defibrillation
The device is protected against the energy that is normally induced by external defibrillation. Nevertheless, any implanted device may be damaged by external defibrillation.
Specifically, the current induced in the implanted leads may result in necrotic tissue
formation close to the electrode/tissue interface. As a result, sensing properties and
pacing thresholds may change.
Due to possible damage to the patient or the device, the use of the following procedures
is contraindicated:
•
Therapeutic ultrasound and diathermy
—
Damage to the patient via excess warming of body tissue near the device
system
•
Radiation therapy
—
Shield the device sufficiently against radiation.
—
Check the system for integrity after applying radiation.
—
Radiation can cause latent damage.
•
Transcutaneous Electrical Nerve Stimulation (TENS)
•
Lithotripsy
•
Magnetic resonance imaging and the associated magnetic flux density
—
Damage or destruction of the device system due to strong magnetic interaction
—
Damage to the patient via excess warming of body tissue near the device
system
•
Electrocautery and high-frequency surgery
—
Damage to the patient via the induction of arrhythmia or ventricular fibrillation
•
Hyperbaric oxygen therapy
•
Applied pressures higher than normal pressure
W
CAUTION
Transmission of atrial tachycardia to the ventricle
Set the following parameters to avoid unphysiological pacing in the ventricle in cases
of high atrial rates or sinus tachycardia:
•
Activate Mode Switching for indicated patients.
•
Set the upper rate and the refractory periods to prevent abrupt ventricular rate
switching.
•
Prefer Wenckebach response and avoid 2:1 behavior.
Set all parameters to prevent constant switching between atrial and ventricle controlled modes to prevent unphysiological rhythm switching upon loss of AV sequential
pacing.
W
CAUTION
Pacemaker-mediated tachycardia in cases of retrograde conduction
Pacemaker-mediated tachycardia can occur in patients with retrograde conduction.
•
Measure the retrograde conduction time.
•
Switch on PMT protection to prevent pacemaker-mediated tachycardia.
•
Set the VA criterion.
Note:
Place adhesive electrodes anterior-posterior or perpendicular to the axis
formed by the device to the heart at least 10 cm away from the device and from
implanted leads.
W
CAUTION
Interference with the device and risk to the patient due to electrical current during
medical treatment
If electrical current from an external source is conducted through the body for diagnostic or therapeutic purposes, then the device has to be switched off or carefully
monitored during the initial treatment phases.
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12
Possible Technical Complications
•
Device component failures
•
Battery depletion
•
Lead dislocation
•
Lead fracture
•
Insulation defect
Possible Interference
Possible impairments due to EMI
All devices (PM/ICD) are susceptible to interference. The signals generated by sources
of interference could be interpreted as heart activity by the device, and/or could disturb
measurements required for adapting the rate of the device:
•
Depending on the pacing mode and the type of interference, these sources of interference may lead to pacemaker pulse inhibition or triggering, an increase in the
sensor-dependent pacing rate, or a fixed-rate pulse delivery.
•
Under unfavorable conditions, for example during diagnostic or therapeutic procedures, the interference sources may induce such a high level of energy into the
artificial pacing system that the device and/or cardiac tissue around the lead tip is
damaged.
•
BIOTRONIK devices have been designed so that their susceptibility to EMI is minimized.
•
However, due to the variety and intensity of EMI, absolute safety is not possible. It is
generally assumed that EMI produces only minor symptoms, if any, in patients.
Static magnetic fields
Above a flux density of 1.8 mT, the Reed contact in the ICD closes; the ICD therapy is
then deactivated. If the magnetic field decreases to below 1 mT, the Reed contact opens
and the ICD therapy is active again.
Possible sources of interference
Interference can be caused by:
•
Household appliances
•
Safety locks or anti-theft installations
•
Strong electromagnetic fields
•
Cellular phones and transmitters (CardioMessenger)
—
Patients are advised to hold cellular phones to the ear opposite the side on
which the device is implanted. Furthermore the cellular phone or transmitter
should be held at least 15 cm away.
—
Cellular phones and transmitters emit signals when in stand-by mode, i.e.
when not in use. Therefore these devices should not be carried in a breast
pocket or within a radius of 15 cm around the implanted device.
—
Electromagnetic interference only has a temporary effect. Implanted devices
function again properly when the cellular phone or transmitter is moved away.
Technical Data
Bradycardia Therapy Parameters
Pacing Modes
Lumax 540 family
The following pacing modes are available:
W
CAUTION
Technical failures due to damaged leads
Switch the automatic impedance measurement function on to detect lead errors.
Impedance values that indicate a loss of lead integrity are documented in the event
list.
Note:
Indicate the possibility of interference to your patient if this is expected to have
a clinically relevant impact. Protect the device against the interference itself or its
effect by means of appropriate programming.
Device type Pacing modes Standard
DR-T;
HF-T
DDD, DDDR,
DDI, DDIR,
VDD, VDDR,
VDI, VDIR,
VVI, VVIR,
AAI, AAIR,
OFF
DDD
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13
Timing Parameters Lumax DR-T
Basic rate day/night
Rate hystereses
AV delay
AV hystereses
IRSplus
Post-ventricular atrial refractory period
VR-T VVI, VVIR,
OFF
VVI
VR-T DX VDD, VDDR,
VDI, VDIR,
VVI, VVIR
OFF
VVI
Parameter Range of values Standard
Basic rate 30 ... (5) ... 100 ... (10) ... 160 ppm 60 ppm
Night rate OFF
30 ... (5) ... 100 ppm
OFF
Night begins 00:00 ... (1 min) ... 23:59 hh:mm 22:00:00 hh:m
m
Night ends 00:00 ... (1 min) ... 23:59 hh:mm 06:00 hh:mm
Parameter Range of values Standard
Rate hysteresis OFF
-5 ... (-5) ... -90 ppm
OFF
Repetitive hysteresis OFF
1 ... (1) ... 15
OFF
Scan hysteresis OFF
1 ... (1) ... 15
OFF
Parameter Range of values Standard
AV delay Low; medium; high; fixed; individual Low
AV delay 1
at rate 1
15 (fixed); 40 ... (5) ... 350 ms
30 ... (10) ... 150 ppm
–
60 ppm
Device type Pacing modes Standard
AV delay 2
at rate 2
40 ... (5) ... 350 ms
40 ... (10) ... 160 ppm
–
130 ppm
Sense compensation OFF
-5 ... (5) ... -60 ms
-30 ms
Safety window 100 ms 100 ms
Parameter Range of values Standard
AV hysteresis mode OFF
Positive; Negative; IRSplus (only for
DR devices)
OFF
AV hysteresis 10 ... (10) ... 150 ms 50 ms
Positive repetitive AV hysteresis OFF
1 ... (1) ... 10
OFF
Negative repetitive AV hysteresis OFF
1 ... (1) ... 15 ... (5) ... 100 ... (10) ... 180
OFF
AV scan hysteresis OFF
1 ... (1) ... 10 ms
OFF
Parameter Range of values Standard
IRSplus OFF; ON OFF
AV hysteresis at IRSplus 400 ms 400 ms
Repetitive AV hysteresis at IRSplus OFF
1 ... (1) ... 10
5
AV scan hysteresis at IRSplus OFF
1 ... (1) ... 10
5
Parameter Range of values Standard
PVARP AUTO
175 ... (25) ... 600 ms
250 ms
Parameter Range of values Standard
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PVC classification; PVC lock-in protection
Upper rate (UTR)
Mode switching
Post Mode Switching Response (PMSR)
PMT protection
Pulse amplitude and pulse width
Automatic threshold monitoring
Automatic threshold monitoring (ATM)
Timing Parameters Lumax 540 VR-T DX
Basic rate day/night
Rate hystereses
PVARP after PVC PVARP + 225 ms (max: 600 ms) is
automatically programmed
475 ms
Parameter Range of values Standard
PVC discrimination after A
s
250 ... (50) ... 450 ms 350 ms
Parameter Range of values Standard
Upper rate 90 ... (10) ... 160 ppm 130 ppm
Atrial upper rate OFF
240 ppm
240 ppm
Parameter Range of values Standard
Intervention rate OFF
100 ... (10) ... 250 ppm
160 ppm
Onset criterion X 3 ... (1) ... 8 5
Resolution criterion Y 3 ... (1) ... 8 5
Mode DDI; DDI(R) when permanent DDD(R)
VDI, VDI(R) when permanent VDD(R)
DDI
VDI
Parameter Range of values Standard
Post mode switching rate OFF
+5 ... (5) ... +50 ppm
+10 ppm
Post mode switching duration 1 ... (1) ... 30 min 1 min
Parameter Range of values Standard
PMT detection/termination OFF; ON ON
VA criterion 250 ... (10) ... 500 ms 350 ms
Parameter Range of values Standard
Parameter Range of values Standard
Pulse amplitude A 0.2 ... (0.1) ... 6.2; 7.5 V 2.8 V
Pulse width A 0.4; 0.5; 0.7; 1.0; 1.2; 1.5 ms 0.4 ms
Pulse amplitude RV 0.2 ... (0.1) ... 6.2; 7.5 V 2.8 V
Pulse width RV 0.4; 0.5; 0.7; 1.0; 1.2; 1.5 ms 0.4 ms
Parameter Range of values Standard
ATM RV ON; OFF ON
Parameter Range of values Standard
Basic rate 30 ... (5) ... 100 ... (10) ... 160 ppm 60 ppm
Night rate OFF
30 ... (5) ... 100 ppm
OFF
Begin of night 00:00 ... (1 min) ... 23:59 hh:mm 22:00 hh:mm
Night ends 00:00 ... (1 min) ... 23:59 hh:mm 06:00 hh:mm
Parameter Range of values Standard
Rate hysteresis OFF
-5 ... (-5) ... -90 ppm
OFF
Repetitive hysteresis OFF
1 ... (1) ... 15
OFF
Scan hysteresis OFF
1 ... (1) ... 15
OFF
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15
AV delay
AV hystereses
IRSplus
Post-ventricular atrial refractory period
PVC classification; PVC lock-in protection
Upper rate (UTR)
Mode switching
Post Mode Switching Response (PMSR)
PMT protection
Pulse amplitude and pulse width
Parameter Range of values Standard
AV delay Low; Medium; High; Fixed; Individual Low
AV delay 1
at rate 1
15 (fixed); 40 ... (5) ... 350 ms
30 ... (10) ... 150 ppm
–
60 ppm
AV delay 2
at rate 2
40 ... (5) ... 350 ms
40 ... (10) ... 160 ppm
–
130 ppm
Parameter Range of values Standard
AV hysteresis mode OFF
Positive; Negative; IRSplus
OFF
AV hysteresis 10 ... (10) ... 150 ms 50 ms
Positive repetitive
AV hysteresis
OFF
1 ... (1) ... 10
OFF
Negative repetitive
AV hysteresis
OFF
1 ... (1) ... 15 ... (5) ... 100 ... (10) ... 180
OFF
AV scan hysteresis OFF
1 ... (1) ... 10
OFF
Parameter Range of values Standard
IRSplus OFF; ON OFF
AV hysteresis at IRSplus 400 ms 400 ms
Repetitive AV hysteresis at IRSplus OFF
1 ... (1) ... 10
5
AV scan hysteresis at IRSplus OFF
1 ... (1) ... 10
5
Parameter Range of values Standard
PVARP AUTO; 175 ... (25) ... 600 ms 250 ms
PVARP after PVC PVARP + 225 ms (max: 600 ms) is
automatically programmed
475 ms
Parameter Range of values Standard
PVC discrimination after A
s
250 ... (50) ... 450 ms 350 ms
Parameter Range of values Standard
Upper rate 90 ... (10) ... 160 ppm 130 ppm
Atrial upper rate OFF
240 ppm
240 ppm
Parameter Range of values Standard
Intervention rate OFF
100 ... (10) ... 250 ppm
160 ppm
Activation criterion X 3 ... (1) ... 8 5
Deactivation criterion Y 3 ... (1) ... 8 5
Mode VDI, VDI(R) when permanent VDD(R) VDI
Parameter Range of values Standard
Post mode switching rate OFF
+5 ... (5) ... +50 ppm
+ 10 ppm
Post mode switching duration 1 ... (1) ... 30 min 1 min
Parameter Range of values Standard
PMT detection/termination OFF; ON ON
VA criterion 250 ... (10) ... 500 ms 350 ms
Parameter Range of values Standard
Pulse amplitude RV 0.2 ... (0.1) ... 6.2; 7.5 V 2.8 V
Pulse width RV 0.4; 0.5; 0.7; 1.0; 1.2; 1.5 ms 0.4 ms
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Automatic threshold monitoring
Automatic threshold monitoring (ATM)
Timing Parameters Lumax VR-T
Basic rate day/night
Rate hysteresis
Pulse amplitude and pulse width
Automatic threshold monitoring
Automatic threshold monitoring (ATM)
Timing Parameters Lumax HF-T
Ventricular pacing
VV delay after Vp
Pacing polarity
Mode switching
Parameter Range of values Standard
ATM RV ON; OFF ON
Parameter Range of values Standard
Basic rate 30 ... (5) ... 100 ... (10) ... 160 ppm 60 ppm
Night rate OFF
30 ... (5) ... 100 ppm
OFF
Begin of night 00:00 ... (1 min) ... 23:59 hh:mm 22:00 hh:mm
End of night 00:00 ... (1 min) ... 23:59 hh:mm 06:00 hh:mm
Parameter Range of values Standard
Rate hysteresis OFF
-5 ... (-5) ... -90 ppm
OFF
Repetitive hysteresis OFF
1 ... (1) ... 15
OFF
Scan hysteresis OFF
1 ... (1) ... 15
OFF
Parameter Range of values Standard
Pulse amplitude V 0.2 ... (0.1) ... 6.2; 7.5 V 2.8 V
Pulse width V 0.4; 0.5; 0.7; 1.0; 1.2; 1.5 ms 0.5 ms
Parameter Range of values Standard
ATM RV ON; OFF OFF
Parameter Range of values Standard
Ventricular pacing RV, BiV for: DDD(R); DDI(R);
VDD(R); VDI(R);VVI(R)
LV for: DDD(R); VDD(R)
BiV
LV T-wave protection OFF; ON ON
Triggering OFF
RVs; RVs+RVES
RVs
Maximum trigger rate AUTO; 90 ... (10) ... 160 ppm AUTO
Parameter Range of values Standard
Initially paced chamber RV; LV LV
VV delay 0 ... (5) ... 100 ms 5 ms
VV delay after V
s
0 ms
Parameter Range of values Standard
Polarity pace LV LV tip/LV ring (bipolar 1)
LV tip/RV ring (common ring bipolar 2)
LV ring/LV tip (inverse bipolar 3)
LV ring/RV ring (ring-to-ring bipolar 4)
LV tip/LV ring
Parameter Range of values Standard
Intervention rate OFF
100 ... (10) ... 250 ppm
160 ppm
Activation criterion X 3 ... (1) ... 8 5
Deactivation criterion Y 3 ... (1) ... 8 5
Mode VDI; VDI(R) when permanent VDD(R) VDI
Ventricular pacing RV; BiV BiV
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Automatic threshold monitoring
Automatic threshold monitoring (ATM)
Rate Adaptation
Accelerometer
Tachyarrhythmia Therapy – Parameters
Sensing Parameters
Atrium
Lumax VR-T DX, DR-T; HF-T
Right ventricle
Lumax VR-T, VR-T DX, DR-T, HF-T
LV T-wave protection OFF; ON ON
Triggering OFF
RVs; RVs + PVC
RVs
Modification of basic rate OFF; +5 ... (5) ... +30 ppm +10 ppm
Parameter Range of values Standard
ATM RV ON; OFF ON
ATM LV ON; OFF ON
Parameter Range of values Standard
Maximum sensor
rate
AUTO
90 ... (5) ... 160 ppm
120 ppm
Sensor gain 1.0; 1.1; 1.3; 1.4; 1.6; 1.8; 2.0; 2.2; 2.6; 3.0; 3.3; 3.7;
4.0; 4.5; 5.0; 6.0; 7.0; 8.0; 9.0; 10; 11; 12; 14; 16; 18;
20; 22; 24; 28; 32; 35; 40
6.0
Automatic gain OFF; ON OFF
Sensor threshold•Very low = 0
•
Low = 3
•
Medium = 7
•
High = 11
•
Very high = 15
Medium
Rate increase 0.5; 1 ... (1) ... 6 ppm/cycle 2 ppm/cycle
Rate decrease 0.25 ...(0.25)... 1.25 ppm/cycle 0.5 ppm/cycle
Parameter Range of values Standard
Parameter Range Standard
Sensing
•
STD - standard
•
OFF - disabled
•
IND - individual change in
sensing details
STD
Minimum threshold 0.2 ... (0.1) ... 2.0 mV 0,4 mV
Far-field protection after Vp 50 ... (25) ... 225 ms 75 ms
Far-field protection after Vs OFF
25 ... (25) ... 225 ms
75 ms
Upper threshold DR, HF 50; 75; 87,5% 50%
Upper threshold DX 50; 75; 87,5% 75%
Lower threshold 12,5; 25; 50% 25%
Parameter Range Standard
Sensing RV
•
STD — standard
•
TWS — extended T-wave suppression
•
VFS — extended VF sensitivity
•
IND — individual change in
sensing details
STD
Minimum threshold 0.5 ... (0.1) ... 2.5 mV 0.8 mV
Blanking after atrial pacing 50 ... (10) ... 100 ms 50 ms
Upper threshold 50; 75; 87,5% 50%
Hold of upper threshold 100 ... (20) ... 600 ms 360 ms
Lower threshold 12,5; 25; 50% 25%
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18
Left ventricle
Lumax HF-T
Polarity sense
Lumax HF-T
Detection Parameters
Detection intervals
Detection counter
Onset
Stability
SMART detection
Sustained VT; without SMART, without SMART redetection
Blanking after RV pacing AUTO
100 ... (10) ... 350 ms
AUTO
Post pace T-wave suppression ON; OFF OFF
Parameter Range Standard
Sensing LV
•
STD - standard
•
OFF - disabled
•
IND - individual change in sensing
details
STD
Minimum threshold 0.5 ... (0.1) ... 2.5 mV 1,6 mV
Upper threshold 50; 75; 87.5% 50%
Hold of upper threshold 100 ... (20) ... 600 ms 360 ms
Lower threshold 12,5; 25; 50% 50%
Parameter Range Standard
LV polarity sense UNIP (LV tip/housing)
BIPL (LV tip/LV ring)
UNIP
Parameter Range Standard
Interval VT1 OFF
270 ... (10) ... 600 ms
OFF
Interval VT2 OFF
270 ... (10) ... 500 ms
OFF
Interval VF OFF
200 ... (10) ... 400 ms
300 ms
Parameter Range Standard
Parameter Range Standard
Detection counter VT1 10 ... (2) ... 60 26
Detection counter VT2 10 ... (2) ... 40 16
Detection counter VF - X 6 ... (1) ... 30 8
Detection counter VF - Y 8 ... (1) ... 31 12
Parameter Range Standard
Onset criterion in VT1/VT2
with SMART
20% 20%
Onset criterion in VT1/VT2
without SMART
OFF
4 ... (4) ... 32%
20%
Parameter Range Standard
Stability in VT1/VT2 with SMART 12% 12%
Stability in VT1/VT2
without SMART
OFF
8 ... (4) ... 48 ms
24 ms
Stability ATP One Shot 12% 12%
Parameter Range Standard
SMART detection VT1 OFF; ON ON
SMART detection VT2 OFF; ON ON
Parameter Range Standard
Sustained VT OFF
00:30; 01:00; 02:00; 03:00; 05:00; 10:00;
15:00; 20:00; 25:00; 30:00 [mm:ss]
OFF
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19
Forced termination; with SMART, SMART redetection
Redetection counter
Therapy Parameters
Ventricle
ATP parameters
ATP One Shot parameters; ATP in VF
Parameter Range Standard
Forced termination OFF 1 ... (1) ... 15 min 1 min
Parameter Range Standard
Redetection counter VT1 10 ... (2) ... 30 20
Redetection counter VT2 10 ... (2) ... 30 14
Parameter Range Standard
Energy of 1st shock and 2nd
shock VT1, VT2
OFF 1 ... (1) ... 16 ... (2) ... 40 J 40 J
Energy of 1st shock and 2nd
shock VF
1 ... (1) ... 16 ... (2) ... 40 J 40 J
Shock sequences 3rd-nth shock
in VT1
OFF
1*40 J; 2*40 J; 3*40 J; 4*40 J;
5*40 J; 6*40 J
6*40 J
Shock sequences 3rd-nth shock
in VF
OFF
4*40 J; 5*40 J; 6*40 J
6*40 J
Number of shocks
(VT1/VT2)
0 ... (1) ... 8 8
Number of shocks (VF) 2; 6 ... (1) ... 8 8
Confirmation in VT1, VT2, VF OFF; ON ON
Shock form in VT1, VT2, VF Biphasic; biphasic2 Biphasic
Polarity in VT1, VT2, VF Normal; inverse; alternating Normal
Shock path (valid for all shocks
including the painless shock
impedance)
RV SVC + housing
RV housing
RV SVC
RV SVC +
housing
Shock path DX RV housing
Parameter Range Standard
ATP type Burst; Ramp; Burst + PES Burst
ATP attempts OFF
1 ... (1) ... 10
3
Ventricular pacing
(HF devices only)
RV; LV; BiV RV
Number S1 1 ... (1) ... 10 5
Add. S1 OFF; ON ON
R-S1 interval 200 ... (10) ... 500 ms (absolute);
70 ... (5) ... 95% (adaptive)
80%
S1 decrement 5 ... (5) ... 40 ms 10 ms
Scan decrement OFF
5 ... (5) ... 40 ms
OFF
S1-S2 interval 200 ... (10) ... 500 ms (absolut);
70 ... (5) ... 95% (adaptive)
70%
Minimum ATP interval 200 ... (5) ... 300 ms 200 ms
ATP timeout OFF
00:15 ... (00:15) ... 05:00 mm:ss
OFF
ATP optimization OFF; ON OFF
ATP pulse amplitude 7.5 V 7.5 V
ATP pulse width 1.5 ms 1.5 ms
Parameter Range Standard
ATP type OFF;
Burst; Ramp; Burst + PES
OFF
ATP attempts 1 1
Ventricular pacing
(HF devices only)
RV; LV; BiV RV
Number S1 1 ... (1) ... 10 8
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Progressive course of therapy
Post-shock pacing
Diagnostics Functions
Home Monitoring, Holter Memory and Statistics
Home Monitoring
Holter episodes
Statistics
R-S1 interval 200 ... (10) ... 350 ms (absolute);
70 ... (5) ... 95% (adaptive)
85%
S1 decrement 5 ... (5) ... 40 ms 10 ms
S1-S2 interval 200 ... (10) ... 350 ms (absolute);
70 ... (5) ... 95% (adaptive)
70%
Stability 12% 12%
ATP pulse amplitude 7.5 V 7.5 V
ATP pulse width 1.5 ms 1.5 ms
Parameter Range Standard
Progressive course of therapy OFF; ON ON
Parameter Range Standard
Pacing mode
(automatically programmed)
•
DDI when permanent DDD(R),
DDI(R), AAI(R)
•
VDI when permanent VDD(R),
VDI(R)
•
VVI when permanent VVI(R);
•
OFF
Basic rate 30 ... (5) ... 100 ... (10) ... 160 ppm 60 ppm
Rate hysteresis OFF
-5 ... (-5) ... -65 ppm
OFF
AV delay 50 ... (10) ... 100 ... (10) ... 160 ms 140 ms
Ventricular pacing RV; BiV RV
LV T-wave protection OFF; ON ON
Triggering OFF
RVs; RVs + PVC.
OFF
Post-shock duration OFF
00:10 ... (00:10) ... 00:50; 01:00 ...
(01:00) ... 10:00 mm:ss
00:10 mm:ss
Parameter Range Standard
Parameter Range Standard
Home Monitoring OFF; ON OFF
Time of transmission 00:00 ... (1 min) ... 23:59 hh:mm 01:00 hh:mm
IEGM for therapy episodes OFF; ON OFF
IEGM for monitoring episodes OFF; ON OFF
Periodic IEGM OFF
2; 3; 4; 6 months
OFF
Sustained atrial episodes (DR, HF) OFF
0.5; 6; 12; 18 h
12 h
Thoracic impedance ON; OFF OFF
Parameter Range Standard
AT/AF OFF; ON ON
SVT OFF; ON ON
Parameter Range Standard
AT/AF rate 100 ... (10) ... 250 bpm 200 bpm
Start resting period 0:00 ... (10) ... 23:50 hh:mm 02:00 hh:mm
Resting period duration 0:00 ... (10) ... 23:50 hh:mm 04:00 hh:mm
Automatic impedance
measurement
VR, DX, DR: ON; OFF
HF: ON; OFF; LV OFF
ON
Thoracic impedance ON; OFF OFF
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21
Characteristics
Electrical Characteristics
Measuring conditions
If not indicated otherwise, all specifications refer to the following conditions:
•
Ambient temperature of 37ºC 2°C and 500 5% load (pacing/sensing) or
50 1% load (shock)
•
Software used: Programmer in standard program
Standards
The specifications are made according to EN 45502-2-2:2008.
Factory settings
All therapy parameters are deactivated at delivery.
Home Monitoring
Telemetry data
Atrial pacing pulse
Lumax DR-T; Lumax HF-T
Ventricular pacing pulse
Lumax VR-T; Lumax VR-T-DX; Lumax DR-T right ventricle; Lumax HF-T right and left
ventricle; except for polarity pace LV ring/ LV tip inverse bipolar
Lumax HF-T left ventricle; polarity pace LV ring/LV tip inverse bipolar
Arrhythmia classes VT1, VT2, VF Antibradycardia pacing Home Monitoring
OFF OFF OFF
Nominal carrier frequency Maximum power of transmission
403.62 MHz
25 W (-16 dBm)
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22
Resistance to interference
With unipolar sensing, the requirements of EN 45502-2-2:2008 are met for interference
voltages 0.6 mV (peak to peak).
EMC requirements relating to section 27.5 are met as long as atrial sensitivity is set to
1.0 mV (corresponds to factory settings) or higher ( 1.0 mV). Appropriate measures
must be taken to assure interference-free therapy if more sensitive values are chosen.
Common mode rejection
Indication of rate in Hz, of common mode rejection in dB:
ATP amplitude
Set parameters:
Results:
Sensitivity setting
Indication of minimum and maximum of automatic sensitivity setting; measurement of
the actual values with positive and negative polarity:
Rate Atrium Atrium V right V left
VR-T DX VR-T, DR-T, HF-T
CMRR (Common Mode Rejection Ratio)
16.667656464
50 80 80 67 64
60 81 75 66 63
Burst Value
Amplitude 7.5 V
Pulse width 1.5 ms
R-S1 interval 300 ms
Number S1 5
Load resistance 500
ATP amplitude Value with tolerance Measured minimum Measured maximum
RV
Mean value
7.5 V 1,5 V
—
7.42 V
5.18 V
7.50 V
5.18 V
LV
Mean value
7.5 V 1.5 V
—
7.50 V
5.18 V
7.50 V
5.18 V
BiV
Mean value
7.5 V 1.5 V
—
7.42 V
5.16 V
7.50 V
5.18 V
Note:
The programmed atrial sensitivity is intensified by a factor of 5 for
Lumax 540 VR-T DX.
Sensitivity Test signal wave
shape
Value Tolerance Measured
value
A: positive [mV]
sin2 15 ms
0.2 0.2 ... 0.5 0.26
Standard triangle — 0.41
A: negative [mV]
sin2 15 ms
0.2 0.2 ... 0.5 0.28
Standard triangle — 0.43
VR-T DX: A: positive
[mV]
sin2 15 ms
0.2 0.02 ... 0.10
(0.1 - 0.5)
0.08
Standard triangle — 0.08
VR-T DX:
A: negative [mV]
sin2 15 ms
0.2 0.02 ... 0.10
(0.1 - 0.5)
0.10
Standard triangle — 0.12
RV: positive [mV]
sin2 40 ms
0.5 0.3 ... 0.7 0,56
Standard triangle — 0.58
RV: negative [mV]
sin2 40 ms
0.5 0.3 ... 0.7 0.45
Standard triangle 0.58
LV: positive [mV]
sin2 40 ms
0.5 0.3 ... 0.7 0.64
Standard triangle 0.65
LV: negative [mV]
sin2 40 ms
0.5 0.3 ... 0.7 0.54
Standard triangle — 0.68
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23
Shock energies / peak voltages at: RV SVC + housing
Lumax 540 VR-T, VR-T DX, DR-T, HF-T as 40 J device with shock path:
RV SVC + housing
Shock energies / peak voltages at: RV SVC
Lumax 540 VR-T, VR-T DX, DR-T, HF-T as 40 J device with shock path: RV SVC
Behavior in case of EMI
In case of electromagnetic interference, the device switches into the V00 mode when
the interference rate is exceeded if VVI(R) or VDD(R) pacing mode was set previously, or
into the D00 pacing mode if DDI(R) or DDD(R) pacing mode was set previously.
Mechanical Characteristics
Housing
Materials in contact with body tissue
The following materials of the ICD system have contact with body tissue:
Radiopaque marker
The radiopaque marker is on the left, positioned vertically.
Shock energy set Measurement of shock energy at 50
1 J
E nominal 94% 25%
0.7 ... 1.18 J
E actual 0.81 J
Tolerance range: U max 90 ... 120 V
U max actual 101.01 V
20 J
E nominal 94% 10%
16.9 ... 20.9 J
E actual 17.31 J
Tolerance range: U max 440 ... 480 V
U max actual 465 V
40 J
E nominal 94% 10%
33.8 ... 41.4 J
E actual 35.31 J
Tolerance range: U max 630 ... 670 V
U max actual 656.7 V
Shock energy set Measurement of shock energy at 50
1 J
E nominal 94% 25%
0.7 ... 1.18 J
E actual 0.83 J
Tolerance range: U max 90 ... 120 V
U max actual 104.2 V
20 J
E nominal 94% 10%
16.9 ... 20.9 J
E actual 17.54 J
Tolerance range: U max 440 ... 480 V
U max actual 466.7 V
40 J
E nominal 94% 10%
33.8 ... 41.4 J
E actual 35.60 J
Tolerance range: U max 630 ... 670 V
U max actual 659.3 V
Device type W x H x D in mm Volume in ccm Mass g
VR-T, VR-T DX, DR-T 66 x 55 x 13 37.2 92
HF-T 66 x 59 x 13 39.8 94
Housing Header Sealing plugs, sealing lips
Titanium Epoxy resin Silopren
Manufacturing year Radiopaque marker
nn BIO SH
Shock energy set Measurement of shock energy at 50
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24
ICD leads
Connections
ICD lead configuration
Tolerances
The following tolerances apply to the programmable parameters:
Included Equipment Lumax
Standard
In the sterile container there is:
•
Device of the Lumax product family
•
Blind plug DF, mounted in the header
•
Blind plug IS-1, mounted in the header (only for HF devices)
•
Screwdriver
In the storage package there is:
•
Patient's ICD manual
•
Sterile cover for the PGH programming head of the programmer
•
Implantation protocol
•
Serial number label
•
Patient ID card
•
Follow-up report
•
Warranty card
•
Technical manual
Orders
The devices are available with the following order numbers (some device types are not
available in all countries):
Accessories
All accessories must correspond to the requirements of the EC Directive 90/385/EEC.
•
BIOTRONIK leads
•
BIOTRONIK programming and monitoring devices
•
Permanent magnet M-50
•
For Home Monitoring: BIOTRONIK transmitters
Pacing/sensing Shock
•
VR-T , VR-T DX: 1 x IS-1 bipolar
•
DR-T: 2 x IS-1 bipolar
•
HF-T: 3 x IS-1 bipolar
•
All device types: 2 x DF-1
Connection Lead connector
RV DF-1 connector of the ventricular shock coil
SVC DF-1 connector of the vena cava electrode
S A IS-1 connector of the atrial sense electrode, bipolar
P/S A IS-1 connector of the atrial pace/sense electrode, bipolar
P/S V IS-1 connector of the ventricular pace/sense electrode, bipolar
CS IS-1 connector of the ventricular pace/sense coronary sinus electrode,
bipolar or unipolar
Parameter Tolerance
Pacing pulse amplitudes +20% to -25%
Pacing pulse width
10%
Atrium sensitivity
DR-T, HF-T
For values 0,4 mV: 0.2 mV to 0.52 mV
For values 0.4 mV: +30% to -50%
Atrium sensitivity
VR-T DX
For values 0,4 mV:
–0.1 mV to +0.3 mV; for values 0.4 mV:
+30% to –60%
Sensitivity of right and left ventricle40%
Pacing intervals
20 ms
Escape interval
20 ms
Detection intervals
20 ms
Refractory periods
20 ms
ATP coupling interval
20 ms
Shock coupling interval
20 ms
Shock energy/charging voltage Electrical characteristics: see peak voltages
Device type Order number
540 VR-T 360348
540 VR-T DX 368852
540 DR-T 360346
540 HF-T 360347
Parameter Tolerance
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25
Service Life
Lumax Battery Data
Battery LiS R7
LITRONIK LiS 3192 R7:
Battery GB
GREATBATCH GB 2491:
Lumax Battery Charge Times
Lumax 540 VR-T
Lumax 540 VR-T DX
Lumax 540 DR-T
Lumax 540 HF-T
Lumax Service Times
Legend
Legend for the following service time graphics:
•
X axis: Number of maximum energy charging processes (shocks and capacitor
reforming)
•
Y axis: Longevity in years;
of Home Monitoring devices:
—
1 periodic message per day
—
12 IEGM transmissions per year
•
Maximum energy charging processes per year:
—
A = 4
—
B = 8
—
C = 12
—
D = 16
—
E = 20
Model LiS 3192 R7
Manufacturer LITRONIK GmbH & Co,
01796 Pirna, Germany
System LiMnO2
Usable capacity until EOS 1720 mAh
Battery voltage at BOL (BOS) 3.2 V
Battery ID number shown on the programmer 3
Model GB 2491
Manufacturer GREATBATCH, INC.
Clarence, NY 14031
System Li/SVO/CFx
Usable capacity until EOS 1720 mAh
Battery voltage at BOL (BOS) 3.2 V
Battery ID number shown on the programmer 1
Shock energy Battery type Order number Charge time
at BOL (BOS)
Charge time
at ERI
HE LiS 3192 R7 or
GB 2491
360348
10 s
12 s
Shock energy Battery type Order number Charge time
at BOL (BOS)
Charge time
at ERI
HE LiS 3192 R7 or
GB 2491
368852
10 s
12 s
Shock energy Battery type Order number Charge time
at BOL (BOS)
Charge time
at ERI
HE LiS 3192 R7 or
GB 2491
360346
10 s
12 s
Shock energy Battery type Order number Charge time
at BOL (BOS)
Charge time
at ERI
HE LiS 3192 R7 or
GB 2491
360347
10 s
12 s
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26
Calculation of service times
•
The service times are calculated with the following values:
—
Pulse amplitude: 2.8 V
—
Pulse width: 0.4 ms
—
Pacing impedance: 500
—
Basic rate: 60 ppm
•
Pacing site:
—
Triple-chamber devices: RV
—
Dual-chamber devices: RV and A
—
Triple-chamber devices: RV, LV and A
Lumax 540 VR-T
Service times with LiS 3192 R7 and GB 2491 battery
Lumax 540 VR-T DX
Service times with LiS 3192 R7 and GB 2491 battery
Note:
Devices in the Lumaxfamily should be implanted within 16 months between the
date of manufacture and the use by date as specified on the package.
•
If the ICD is implanted shortly before the use by date, the expected service time
may be reduced by up to 15 months.
•
Please note that four capacitor reformings are carried out per year. Therefore
you have to account for at least 4 shocks per year, even if less than 4 have been
delivered (see the following charts of service times).
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27
Lumax 540 DR-T
Service times with LiS 3192 R7 and GB 2491 battery
Lumax 540 HF-T
Service times with LiS 3192 R7 and GB 2491 battery
Legend for the Label
The label icons symbolize the following:
Manufacturing date
Use by
Storage temperature
BIOTRONIK order number
Serial number
Product identification number
Warning: dangerous voltages!
Sterilized with ethylene oxide
Do not resterilize!
Single use only. Do not reuse!
Non-sterile
Follow the instructions in the
technical manual!
Contents
Do not use if package is
damaged!
STERILIZE
2
NON
STERILE
CE mark
Transmitter with non-ionizing
radiation on specified frequency;
turned off during shipment
Device with NGB coding and
name of compatible ICD leads
(example)
Device with factory settings:
Bradycardia and tachycardia
therapies are set to OFF and/or
the program settings are physiologically ineffective
Screwdriver
Position of connector ports in
the header (example)
Bipolar IS-1 connector
Unipolar IS-1 connector
Unipolar DF-1 connector
A
Atrium
V
Ventricle
CS
Coronary sinus
Pace
Pacing
Sense
Sensing
Shock
Shock
RV
High-voltage connector port
SVC
High-voltage connector port
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28
cs • Česky
Popis systému
Zamýšlené lékařské použití
Lumax je název pro skupinu implantabilních kardioverter-defibrilátorů (ICD).
Primárním cílem léčby je prevence náhlé srdeční smrti. Cílem je automaticky detekovat
a ukončit srdeční zástavu vyvolanou komorovou tachyarytmií. Skupina Lumax zahrnuje
všechny hlavní terapeutické kardiologické a elektrofyziologické přístupy.
Zdravotnický prostředek je dále schopný léčit bradykardické arytmie a městnavé
srdeční selhání. Městnavé srdeční selhání se léčí pomocí srdeční resynchronizační
léčby prostřednictvím 'multisite' komorové stimulace známé jako srdeční
resynchronizační léčba (CRT).
Integrovaná funkce pro domácí monitorování (Home Monitoring) může poskytnout
informace o vyskytujících se poruchách rytmu a podaných léčbách ve skutečném čase
a rovněž pomocí IEGM-Online HD®. Jsou též zasílány statistické údaje o stavu pacienta
a rovněž informace o integritě samotného zdravotnického prostředku.
Implantace ICD je symptomatická léčba, která má následující cíle:
•
ukončení spontánní komorové fibrilace (VF) pomocí šoku;
•
ukončení spontánní komorové tachykardie (VT) pomocí antitachykardické stimulace
(ATP); v případě neúčinné ATP nebo hemodynamicky netolerované VT použitím
šoku;
•
srdeční resynchronizace pomocí 'multisite' komorové stimulace (3dutinový
implantát);
•
kompenzace bradykardie pomocí komorové (1dutinový implantát) nebo AV
sekvenční stimulace (2 a 3dutinový implantát).
Předpokládáné odborné znalosti
Mimo medicínského základu jsou třeba podrobné znalosti funkcí a podmínek použití
implantátového systému. Pouze lékařští odborníci s těmito zvláštními znalostmi mohou
implantáty používat v souladu s ustanovením. Nejsou-li tyto znalosti k dispozici, musí
být uživatel proškolen.
ICD systém
Lumax
ICD systém Lumax se skládá z následujících komponent:
•
1, 2 nebo 3dutinový implantát s konektory pro bipolární snímání a stimulaci
a rovněž s konektory pro šokovou léčbu;
•
ICD elektrody:
—
jedna bipolární ICD elektroda s jednou nebo dvěma impulzními cívkami pro
dutinu (1dutinový implantát),
—
jedna bipolární elektroda pro síň a jedna bipolární ICD elektroda pro komoru
s jednou nebo dvěma impulzními cívkami (2 nebo 3dutinový implantát),
—
jedna uni- nebo bipolární elektroda do koronárního sinu (3dutinový implantát);
•
programátor s aktuálním programem implantátu.
Implantát
Case implantátu je vyrobeno z biokompatibilního titanu, z vnější strany svařeno a tak
hermeticky utěsněno. Case slouží jako potenciální protipól při spuštění výboje.
Elipsovitý tvar usnadňuje implantaci do oblasti pektorálního svalu.
Značení poskytuje informace o typu implantátu a uspořádání konektorů.
Skupina Lumax
Existují tyto typy s funkcí Home Monitoring (ne v každé zemi jsou dostupné všechny typy
implantátů):
Kódy NBD a NBG
VVE je kód NBD pro antitachykardický režim 1-, 2- a 3dutinových implantátů.
Upozornění:
Tri- nebo kvadrupolární RV elektroda má jak bipolární elektrody,
tak 1 nebo 2 impulzní cívky.
Implantát Typ s vysokou energií: max. 40 J
1dutinový Lumax 540 VR-T
Lumax 540 VR-T DX
2dutinový Lumax 540_DR-T
3dutinový Lumax 540 HF-T
VVýboj v komoře
V Antitachykardická komorová stimulace (ATP)
E Detekce skrz vyhodnocení IEGM
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29
DDDR je kód NBG pro antibradykardický režim 2- a 3dutinových implantátů.
VVIR je kód NBG pro antibradykardický režim 1dutinových implantátů.
ICD elektrody
Elektrody jsou vyrobeny z biokompatibilního silikonu. Mohou být flexibilně ovládány,
jsou dlouhodobě stabilní a jsou vybaveny aktivní nebo pasivní fixací. Jsou implantovány
pomocí soupravy pro zavedení elektrody. Některé elektrody jsou potaženy polyuretanem, který zvyšuje kluzné vlastnosti elektrody.
Elektrody se steroidním límcem snižují výskyt zánětu myokardu. Fraktální design
elektrod poskytuje nízké stimulační prahy.
Diagram propojení implantátu/ICD elektrody
ICD firmy BIOTRONIK jsou navrženy pro připojení ICD elektrod s bipolárním připojením
IS-1 (stimulace/snímání) a připojením DF-1 pro impulzní cívky.
Diagramy propojení typů implantátů:
Připojení implantátu a elektrody:
Možné technické závady
Technické závady implantátu v důsledku selhání komponenty nemohou být v podstatě
vyloučeny; vyskytují se však velmi vzácně. Mezi příčiny takových poruch patří:
•
vybití baterie,
•
posunutí elektrody,
•
zlomení elektrody,
•
defekty izolace.
Programátor
Pomocí přenosného programátoru je aktuální implantační program přenášen na implantát. Programátor kromě toho slouží k ověřování a uložení dat do paměti z implantátu. A funguje jako monitor EKG a IEGM s miniklinikou.
Programátor komunikuje s implantátem přes programovací hlavici. Má k dispozici TFT
dotykovou obrazovku s barevným displejem, na kterém jsou současně zobrazeny funkce
EKG, IEGM, markru a přístroje.
Programátor má mezi dalšími tyto funkce:
•
provedení všech testů během prezenčního následného sledování,
•
zobrazení a tisk IEGM v reálném čase a uložených IEGM s popisovanými markry,
•
zjištění stimulačního prahu.
D Stimulace v obou dutinách
D Snímání v obou dutinách
D Inhibice a spuštění impulzu
R Přizpůsobení frekvence
V Komorová stimulace
VSnímání v komoře
I Inhibice impulzu v komoře
R Přizpůsobení frekvence
Upozornění:
Implantát a elektrody musí být vzájemně kompatibilní; k ICD Lumax 540
VR-T DXlez použít pouze elektrody Kentrox A+ nebo Linox Smart DX.
Upozornění:
Bipolární a rovněž unipolární elektroda do koronárního sinu může být
připojena do levého komorového CS konektoru varianty Lumax HF. U bipolární CS
elektrody může být nastaveno několik stimulačních polarit.
VR-T VR-T DX DR-T HF-T
VR-T VR-T DX DR-T HF-T
Síň — IS-1 bipolární
Pravá komora IS-1 bipolární
2 x DF-1 unipolární
Levá komora — IS-1 unipolární nebo bipolární
RV
SVC
SVC
RV
SVC
RV
RV
SVC
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